Trial Outcomes & Findings for Safety Study of Using Symlin Alongside Insulin in a Multiple Injection Port (NCT NCT00790699)
NCT ID: NCT00790699
Last Updated: 2020-10-20
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
3 months
Results posted on
2020-10-20
Participant Flow
Participant milestones
| Measure |
I-PORT
I-PORT: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
|
Standard Injections
standard injections: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections. The standard injections are usually 3-4 times daily.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
14
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of Using Symlin Alongside Insulin in a Multiple Injection Port
Baseline characteristics by cohort
| Measure |
I-PORT
n=17 Participants
I-PORT: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
|
Standard Injections
n=14 Participants
standard injections: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 16.38 • n=5 Participants
|
54 years
STANDARD_DEVIATION 10.60 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 13.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
14 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Glycomark
|
6.49 ug/mL
STANDARD_DEVIATION 3.69 • n=5 Participants
|
5.05 ug/mL
STANDARD_DEVIATION 3.71 • n=7 Participants
|
5.84 ug/mL
STANDARD_DEVIATION 3.71 • n=5 Participants
|
|
Type of Diabetes Breakdown
Type 1 Diabetics
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Type of Diabetes Breakdown
Type 2 Diabetes
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Type 1 diabetes
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
I-PORT
n=17 Participants
I-PORT: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
|
Standard Injections
n=14 Participants
standard injections: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
|
|---|---|---|
|
The Primary Outcome Will be Measured by HbA1c Values Taken at Screening, Baseline and After Three Months.
Screening
|
7.68 % of HbA1c
Standard Deviation .65
|
7.93 % of HbA1c
Standard Deviation .73
|
|
The Primary Outcome Will be Measured by HbA1c Values Taken at Screening, Baseline and After Three Months.
Month 3
|
7.34 % of HbA1c
Standard Deviation .60
|
7.42 % of HbA1c
Standard Deviation .90
|
|
The Primary Outcome Will be Measured by HbA1c Values Taken at Screening, Baseline and After Three Months.
Baseline
|
7.66 % of HbA1c
Standard Deviation .35
|
7.70 % of HbA1c
Standard Deviation .67
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Results broken down further to reflect results in each group: Iport vs. Standard Injection subjects and total number of subjects who completed the patient reports at visit 1 and Visit 6.
Scores from the QOL and treatment satisfaction measures collected at Visit 1 and Visit 6. To determine if patient satisfaction and patient opinions and attitudes toward using the I-PORT™ for insulin and Symlin® administration compared to standard insulin and Symlin® injections was significantly different for patients in the treatment and control groups, repeated-measures analysis of variance (RM-ANOVA) was conducted on scores from the quality of life and treatment satisfaction measures collected at Visit 1 and Visit 6. The RM-ANOVA results were evaluated to determine if any statistically significant changes occurred. TSQ- lower numbers show less satisfied. DDS- Lower numbers show decrease in distress. DTSQ- Lower numbers show less satisfied. One patient did not complete Visit 6 questionnaires. Scale ranges: DDS scale range: 17- 102 DTSQc scale range: 16- 96 Insulin /Symlin Treatment Satisfaction Questionnaire scale range: 15-90
Outcome measures
| Measure |
I-PORT
n=31 Participants
I-PORT: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
|
Standard Injections
n=30 Participants
standard injections: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
|
|---|---|---|
|
The Secondary Outcome Will Measure Patient Satisfaction, Opinions and Attitudes Toward Using the Multiple Injection Port for Insulin and Symlin Administration Compared to Standard Symlin Injections (Measured Through Using Questionnaires).
Treatment Satisfaction Control
|
66.07 units on a scale
Standard Deviation 13.34
|
65.66 units on a scale
Standard Deviation 13.94
|
|
The Secondary Outcome Will Measure Patient Satisfaction, Opinions and Attitudes Toward Using the Multiple Injection Port for Insulin and Symlin Administration Compared to Standard Symlin Injections (Measured Through Using Questionnaires).
DTSQ Treatment
|
35.41 units on a scale
Standard Deviation 6.78
|
33.25 units on a scale
Standard Deviation 6.15
|
|
The Secondary Outcome Will Measure Patient Satisfaction, Opinions and Attitudes Toward Using the Multiple Injection Port for Insulin and Symlin Administration Compared to Standard Symlin Injections (Measured Through Using Questionnaires).
Diabetes Distress Scale Control
|
38.20 units on a scale
Standard Deviation 10.56
|
33.86 units on a scale
Standard Deviation 8.19
|
|
The Secondary Outcome Will Measure Patient Satisfaction, Opinions and Attitudes Toward Using the Multiple Injection Port for Insulin and Symlin Administration Compared to Standard Symlin Injections (Measured Through Using Questionnaires).
Diabetes Distress Scale Treatment
|
34.00 units on a scale
Standard Deviation 10.57
|
31.45 units on a scale
Standard Deviation 10.74
|
|
The Secondary Outcome Will Measure Patient Satisfaction, Opinions and Attitudes Toward Using the Multiple Injection Port for Insulin and Symlin Administration Compared to Standard Symlin Injections (Measured Through Using Questionnaires).
DTSQ Control
|
37.46 units on a scale
Standard Deviation 5.95
|
34.54 units on a scale
Standard Deviation 7.40
|
|
The Secondary Outcome Will Measure Patient Satisfaction, Opinions and Attitudes Toward Using the Multiple Injection Port for Insulin and Symlin Administration Compared to Standard Symlin Injections (Measured Through Using Questionnaires).
Treatment Satisfaction Treatment
|
67.16 units on a scale
Standard Deviation 12.30
|
54.28 units on a scale
Standard Deviation 16.71
|
Adverse Events
Iport
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Standard Injections
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Iport
n=16 participants at risk
Treatment group/ Iport Users
|
Standard Injections
n=14 participants at risk
Control group/ Standard Injections
|
|---|---|---|
|
Infections and infestations
Upper respiratory infections
|
18.8%
3/16 • Number of events 3 • 2 years
|
21.4%
3/14 • Number of events 3 • 2 years
|
|
Infections and infestations
Urinary tract infections
|
12.5%
2/16 • Number of events 2 • 2 years
|
0.00%
0/14 • 2 years
|
|
Infections and infestations
Common Cold
|
6.2%
1/16 • Number of events 1 • 2 years
|
14.3%
2/14 • Number of events 2 • 2 years
|
|
Reproductive system and breast disorders
uterine ablation
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
Endocrine disorders
Hyperglycmia
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
Gastrointestinal disorders
Bloating
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
Musculoskeletal and connective tissue disorders
left wrist fracture
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
Eye disorders
Iritis
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
Infections and infestations
Sinus infection
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Dental implants
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
Infections and infestations
Yeast infection
|
6.2%
1/16 • Number of events 1 • 2 years
|
7.1%
1/14 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastroenteritis
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
Infections and infestations
Parvo Virus
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Trigger finger release
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
General disorders
Mettalic taste
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
General disorders
mettalic smell
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
General disorders
confusion
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
Gastrointestinal disorders
Black liquid stool
|
6.2%
1/16 • Number of events 1 • 2 years
|
0.00%
0/14 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • 2 years
|
7.1%
1/14 • Number of events 1 • 2 years
|
|
General disorders
Boil
|
0.00%
0/16 • 2 years
|
7.1%
1/14 • Number of events 1 • 2 years
|
|
General disorders
swollen lymph node
|
0.00%
0/16 • 2 years
|
7.1%
1/14 • Number of events 1 • 2 years
|
|
General disorders
dizziness
|
0.00%
0/16 • 2 years
|
7.1%
1/14 • Number of events 1 • 2 years
|
|
Infections and infestations
tooth abcess
|
0.00%
0/16 • 2 years
|
7.1%
1/14 • Number of events 1 • 2 years
|
|
Infections and infestations
bacterial bronchitis
|
0.00%
0/16 • 2 years
|
7.1%
1/14 • Number of events 1 • 2 years
|
|
Infections and infestations
pneumonia
|
0.00%
0/16 • 2 years
|
7.1%
1/14 • Number of events 1 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place